Tag: Drug Approvals
FDA Gives OK to Merck Antiviral At-Home COVID-19 Pill
Molnupiravir cut the risk for hospitalization and death in high-risk patients by 30 percent
FDA Approves Pfizer Pill as First At-Home COVID-19 Treatment
Recent trial showed Paxlovid cut the odds for hospitalization and death by nearly 90 percent in high-risk people
FDA Approves First-in-Class Treatment for Myasthenia Gravis
Vyvgart is the first neonatal Fc receptor blocker to be approved to treat generalized myasthenia gravis in patients testing positive for AChR antibody
FDA Approves Imaging Drug That Can Help Surgeons Spot Ovarian Cancers
Drug is designed to improve surgeon's ability to detect ovarian cancer while operating on a patient
FDA Approves First Interchangeable Biosimilar for Inflammatory Diseases
Cyltezo is first interchangeable monoclonal antibody for RA, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, chronic plaque psoriasis
First Biosimilar Approved for Macular Degeneration, Other Eye Conditions
Biosimilar to Lucentis approved to treat neovascular age-related macular degeneration, macular edema, myopic choroidal neovascularization
Precedent Needed for FDA Approval Decisions When Evidence Lacking
In seven of 22 cases, approval used new interpretations of original evidence and did not require new evidence
Xywav Gets FDA Approval to Treat Rare Sleep Disorder
First drug to be approved by the agency for idiopathic hypersomnia
Enzyme Replacement Therapy Approved for Late-Onset Pompe Disease
Patients taking Nexviazyme saw improvements in respiratory function and walking distance measures
REGEN-COV Authorized for Postexposure Prophylaxis in High-Risk Individuals
Emergency use authorization indicated for those who have been exposed to SARS-CoV-2 and have an immunocompromising condition
